Biohaven Pharmaceutical (NYSE:BHVN)
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6 Months : From Jun 2019 to Dec 2019
NEW HAVEN, Conn., July 11, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced it will present 16 scientific presentations (oral and poster) highlighting new efficacy and safety data for rimegepant from Biohaven's robust clinical development program at the American Headache Society (AHS) Annual Scientific Meeting in Philadelphia, July 11-14, 2019. Notably, Biohaven will be presenting results from the rimegepant Zydis® oral fast-dissolve tablet (ODT) Phase 3 trial, new analyses across the three Phase 3 trials, results from the rimegepant long-term safety study, and new clinical pharmacology data. Rimegepant is an oral, single dose, selective and potent small molecule calcitonin gene-related peptide (CGRP) receptor antagonist in development for the acute treatment of migraine.
"Through 16 presentations at AHS, the premiere national annual headache conference, we are sharing the most extensive positive data set on rimegepant as an acute treatment of migraine," said Vlad Coric, M.D., Chief Executive Officer of Biohaven. "These studies demonstrate that rimegepant is effective for the acute treatment of migraine across multiple patient subsets, including difficult to treat patients with more frequent attacks and those taking concurrent preventive migraine medications as well as patients experiencing nausea."
Richard Lipton, MD, Professor and Vice Chair of Neurology at the Albert Einstein College of Medicine and Montefiore Health System, Director of the Montefiore Headache Center will present the positive results from the randomized, controlled Phase 3 clinical trial (Study 303) evaluating the efficacy and safety of rimegepant Zydis ODT for the acute treatment of migraine on Saturday, July 13 from 8:40 AM ET – 8:50 AM ET (Oral Presentation #IOR05). Dr. Lipton is also a paid consultant and shareholder of Biohaven.
Consistent with the two previous Phase 3 clinical trials for rimegepant oral tablet, Study 303 met its co-primary endpoints of pain freedom and freedom from the most bothersome symptom at two hours using a single dose. Importantly, patients treated with the rimegepant Zydis ODT formulation began to experience pain relief as early as 15 minutes, with numerical separation from placebo, and this difference was statistically significant at 60 minutes (p=0.0314). Additionally, a significantly greater percentage of patients treated with rimegepant Zydis ODT returned to normal functioning by 60 minutes as compared to placebo (p=0.0025). Furthermore, sustained clinical benefit was observed through 48 hours after a single dose of rimegepant on freedom from pain (p<0.0001), pain relief (p<0.0001), freedom from the most bothersome symptom (p=0.0018), and freedom from functional disability (p<0.0001). Superiority over placebo was also demonstrated on additional, clinically relevant secondary endpoints. The vast majority of patients treated with rimegepant Zydis ODT (85%) did not use any rescue medications.
"The results of the Phase 3 study of rimegepant Zydis ODT for the acute treatment of migraine demonstrate the meaningful benefits of this easy-to-use single-dose formulation, with early and sustained relief of symptoms, low use of rescue medications, and low rates of adverse events," said Dr. Lipton. "A new effective, safe, and convenient acute treatment option would be a great advancement for the millions of people around the world whose daily lives are impacted by migraine."
There are a total of 15 additional rimegepant posters being presented at AHS. Posters include:
- Poster #P235LB: Interim results from the long-term, open-label safety study of rimegepant 75 mg in over 1,780 patients with a combined exposure of over 105,000 doses are being presented for the first time at a scientific meeting. Patients were dosed up to one year and were allowed to take rimegepant up to once daily. The drug was well tolerated in adults with migraine, only 2.7% of subjects discontinued due to an adverse event, and there were no signs of hepatoxicity. A cohort with high-frequency, scheduled dosing of rimegepant 75 mg at least every other day demonstrated consistent results with the overall population. Exploratory efficacy analyses from this study demonstrate that rimegepant reduces migraine days when used on an as-needed basis for acute treatment of attacks as well as when dosed on a scheduled basis, suggesting that rimegepant may have dual-therapy action with acute and preventive treatment effects.
- Poster #P239LB: A pooled analysis of results from the three rimegepant Phase 3 trials looked at the efficacy of rimegepant in patients taking concurrent preventive medication and found rimegepant to be more effective than placebo for the acute treatment of migraine. Among subjects on preventive medication (547 subjects, rimegepant n=272, placebo n=275), pooled two-hour pain freedom rates for rimegepant and placebo were 20.6% and 10.2%, respectively (p=0.0007). Additionally, the two-hour rates for freedom from most bothersome symptom were 37.1% for rimegepant and 20.4% for placebo (p<0.0001).
- Poster #P236LB: A pooled analysis of results from the three rimegepant Phase 3 trials looked at the efficacy of rimegepant in patients with high migraine attack frequency (at least four attacks per month), a patient population that has previously been shown to be more difficult to treat, and found rimegepant was an effective acute treatment of migraine. Among subjects with ≥4 moderate or severe attacks per month (2426 subjects, rimegepant n=1217, placebo n=1209), two-hour pain freedom rates for rimegepant and placebo among these patients were 20.6% and 12.6%, respectively (p<0.0001). For two-hour freedom from the most-bothersome symptom, the rates were 35.8% and 26.9% for rimegepant and placebo, respectively (p<0.0001).
- Poster #P238LB: The first clinical report evaluating the efficacy and safety of rimegepant for the acute treatment of migraine for breakthrough attacks in two patients concurrently receiving erenumab, a CGRP receptor binding monoclonal antibody, for preventive treatment of migraine is being presented for the first time in a scientific meeting. The two patients were enrolled in the rimegepant long-term open-label safety study. With rimegepant used as an acute treatment, both patients were able to eliminate use of additional rescue medications and successfully treat their attacks with rimegepant alone. After starting erenumab for preventive treatment, both patients were able to successfully treat breakthrough attacks with oral rimegepant that occurred despite the use of the injectable monoclonal antibody preventive therapy.
Rimegepant is Biohaven's orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist, which the Company is developing as a treatment for migraine. Rimegepant represents a novel mechanism that targets the underlying pathophysiology of migraine without causing vasoconstriction. The efficacy and safety profile of rimegepant for the acute treatment of migraine has now been established across four randomized controlled trials to date: the three completed pivotal Phase 3 trials, and a Phase 2b trial. The co-primary endpoints achieved in all three Phase 3 trials are consistent with regulatory guidance from the FDA for NDA submissions provide the basis for the NDA submissions to the FDA.
Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxidase inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com.
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the effectiveness and safety of rimegepant, the expected timing, commencement and outcomes of the Company's planned and ongoing clinical trials, the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of the Company's product candidates and the potential for the Company's product candidates to be first in class or best in class therapies. The use of certain words, including "believe", "continue", "may", "on track", "expects" and "will" and similar expressions, are intended to identify forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019 and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, filed with the Securities and Exchange Commission on May 8, 2019. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
For further information, contact:
Dr. Vlad Coric
Chief Executive Officer
Sam Brown Inc.
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